Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 517 for:    Open Studies | "Substance-Related Disorders"

HIV & Drug Abuse Prevention for South African Men

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2015 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02358226
First received: November 24, 2014
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to test the efficacy of randomizing all young men in a neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a control condition, as a means to engage young men in HIV prevention. The investigators hypothesize that the intervention will reduce young men's substance use and increase HIV testing.


Condition Intervention Phase
Substance-Related Disorders
Human Immunodeficiency Virus
Alcoholism
Behavioral: Soccer League (SL)
Behavioral: Soccer League/Vocational Training (SL-V)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV & Drug Abuse Prevention for South African Men

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Substance Abuse [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Alcohol and drug use assessed repeatedly using point-of-contact, rapid diagnostic tests over 24 months; Hazardous alcohol use and dependence symptoms self-reported repeatedly over 24 months using the AUDIT-C (a three-item questionnaire)

  • Recent HIV testing [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports of HIV tests over 24 months


Secondary Outcome Measures:
  • Concurrent sexual partnerships [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months

  • Employment [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports of employment over 24 months, validated by external documentation

  • Violence towards Women [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports of violence towards women over 24 months, validated by external documentation

  • Among HIV+, uptake and adherence to ARV medications and medical regimens [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months


Other Outcome Measures:
  • Density and centrality of social networks [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months

  • Community and personal norms regarding HIV stigma, alcohol use, healthy nutrition, and hopefulness for the future [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months

  • Consistency of daily routines [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months

  • Partner's behaviors, and involvement of female partners and father in the home life [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months

  • Values, life goals, and goal for the next month [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Assessed via repeated self-reports over 24 months


Estimated Enrollment: 1200
Study Start Date: July 2015
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soccer League (SL)
In the SL arm, participants will be invited to participate in a Soccer League, led by coaches who meet the criteria of: 1) soccer skills, 2) being a role model, and 3) social competence. Coaches will undergo intensive training in ethics; role-playing the delivery of health messages; conducting brief interventions for alcohol; how to acquire information on HIV, TB, alcohol use and employment; linkages to local clinics, data collection; and Street Smart, an evidence-based intervention for high-risk youth. Coaches will provide pre- and post-game talks, incorporating the topics of alcohol and drugs; interacting positively with health care providers, partners and family members; HIV, diabetes; daily routines; healthy social networks; making and saving money; loyalty and national success.
Behavioral: Soccer League (SL)
Participants will be invited to attend soccer practice in the late afternoons, roughly 2-3 times per week. Competitive games will be held on Saturdays so that friends and family may attend. Using a mobile phone application, coaches will regularly record information on participants' arrival and departure times, sportsmanship, volunteering in the community, the results of saliva tests for drugs and alcohol.
Experimental: Soccer League/Vocational Training (SL-V)
The SL-V arm will include both the SL intervention as well as access to Vocational Training at Khayelitsha College. The program covers several different skills (e.g., math, engineering), including a trade. If participants are able to demonstrate near-perfect attendance, and at least a 50% pass rating in math, engineering and trade theory and practice, their names will be listed in a national artisan database with guaranteed work placement by the recruiting company.
Behavioral: Soccer League/Vocational Training (SL-V)
In addition to the SL intervention, participants will gain access to vocational training. The Vocational Training will take place at Khayelitsha College for a period of 6 months with assessments at the halfway mark. If participants demonstrate near-perfect attendance, and a pass rating of at least 50% in math, engineering, and trade theory and practice, their names will be listed in a national artisan database with guaranteed work placement by recruiting companies.
No Intervention: Control Condition (CC)
Participants in the CC arm will routinely receive flyers with picture stories regarding HIV prevention strategies and how to access these strategies: HIV testing, circumcision, HIV treatment, including ARV, condoms and sexually transmitted diseases.

Detailed Description:

South Africa has the highest number of HIV-infected persons of any nation, including 2.4 million men, and from 2002-2011 young men had a 3% incidence HIV rate that has remained stable (UNAIDS et al., 2011; Barnighausen et al., 2009; Statistics, South Africa, 2013). New infections occur later in men than in women, making men in their 20s a target for intervention (Statistics, South Africa, 2013). Decreasing sexual risk and concurrent partnerships is a key outcome in interventions to reduce HIV incidence (Aral & Peterman, 1996; Epstein, 2007). Most men (68%) report unprotected sex, typically with three partners in the last three months,and more than half of young men do not use condoms with casual partners (Bhana & Pattman, 2009; Reddy et al., 2003; SA DoH & Medical Research Council, 2007; Coovadia et al., 2009).

In South Africa, the amount of alcohol consumed per adult is among the highest in the world (Parry, 2005). 'Heavy episodic drinking', which most strongly correlates with risky sexual behaviors and HIV infection, is reported by 60% of men (Scott-Sheldon et al., 2012). Alcohol, tik (methamphetamine) and marijuana are common among young men in South Africa (Morojele et al., 2006; Parry et al., 2004; Kalichman et al., 2008). Among alcohol abusers, men are highly likely to be poly substance users (Parry & Bennetts, 1998). Among HIV seropositive young men, drug use is common (Parry & Bennetts, 1998). Drug and alcohol use is associated with risky sexual behaviors and an increase in the number of sexual partners (Morojele et al., 2006; Simbayi et al., 2006).

In townships, alcohol is involved in or responsible for 60% of automobile accidents, 75% of homicides, 50% of non-natural deaths, 67% of domestic violence, 30% of hospital admissions, and costs South Africa about R9 billion annually (Parry, 2005; MRC, 2003). Violence also characterizes the lives of young men in the Xhosa townships. Intimate partner violence is frequent in alcohol-using partnerships and is correlated with increased HIV incidence (Jewkes, 2002; Jewkes et al., 2010). Substance use and unemployment often lead to violence in a township. Jobs, by contrast, provide income and create a strong and respected community role.

HIV prevention efforts for young people in Sub-Saharan Africa have largely been unsuccessful: novel, structural, community level programs that address the social determinants of HIV are needed (Michielsen et al., 2010; Dean & Fenton, 2010; UNAIDS, 2010; Gupta et al., 2008). Unemployment and a culture of alcohol and violence are major social determinants of HIV among young men. Yet, men are often excluded from economic development programs. Young, South African men need new pathways for prosocial roles and behaviors and our interventions need to be attractive and consistent with men's styles. The social determinants of HIV (unemployment, alcohol, and violence) are critical to creating opportunities for prosocial roles for young men. One of the most common comments by both the men and their families in our previous pilot qualitative study on soccer and vocational training was men's lack of "things to do." Given these needs, the investigators focus on soccer and vocational training in this randomized controlled trial as opportunities for young men to acquire the habits of daily living that are most likely to result in jobs, health, and positive relationships.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • not employed
  • sleeps at least 4 nights per week in the two months prior to recruitment in a household in the target neighborhood boundaries
  • speaks Xhosa or English
  • provides voluntary informed consent and understands the consent process
  • does not appear to be actively hallucinating or incapable of understanding the interviewer

Exclusion Criteria:

  • if the interviewer reports that the young man demonstrates delusional talk or cannot comprehend the voluntary informed consent forms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02358226

Contacts
Contact: Mary Jane Rotheram, PhD (310) 794-8278 mrotheram@mednet.ucla.edu
Contact: Mark Tomlinson, PhD +27 (21) 808-3446 markt@sun.ac.za

Locations
South Africa
Grassroots Soccer Not yet recruiting
Cape Town, South Africa
Contact: Kelly Baird    +27 21 426 5154    kellyb@grassrootsoccer.org   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Mary Jane Rotheram, PhD Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
  More Information

Publications:

Responsible Party: Mary Jane Rotheram-Borus, Bat-Yaacov Professor of Child Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02358226     History of Changes
Other Study ID Numbers: R01DA038675, 1R01DA038675-01A1
Study First Received: November 24, 2014
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board
South Africa: Human Research Ethics Committee

Keywords provided by University of California, Los Angeles:
Substance-Related Disorders
Human Immunodeficiency Virus
Alcoholism
South Africa
Men
Soccer
Vocational Training

Additional relevant MeSH terms:
Substance-Related Disorders
Acquired Immunodeficiency Syndrome
Alcoholism
HIV Infections
Immunologic Deficiency Syndromes
Alcohol-Related Disorders
Chemically-Induced Disorders
Immune System Diseases
Lentivirus Infections
Mental Disorders
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on February 25, 2015